JP4181225B2 - Medical device for biological tissue treatment - Google Patents

Medical device for biological tissue treatment Download PDF

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JP4181225B2
JP4181225B2 JP50365899A JP50365899A JP4181225B2 JP 4181225 B2 JP4181225 B2 JP 4181225B2 JP 50365899 A JP50365899 A JP 50365899A JP 50365899 A JP50365899 A JP 50365899A JP 4181225 B2 JP4181225 B2 JP 4181225B2
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ハウプト、ゲラルド
メネ、アンドレアス
シュルツ、マンフレッド
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フェルトン オルディング
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    • G—PHYSICS
    • G10—MUSICAL INSTRUMENTS; ACOUSTICS
    • G10K—SOUND-PRODUCING DEVICES; METHODS OR DEVICES FOR PROTECTING AGAINST, OR FOR DAMPING, NOISE OR OTHER ACOUSTIC WAVES IN GENERAL; ACOUSTICS NOT OTHERWISE PROVIDED FOR
    • G10K15/00—Acoustics not otherwise provided for
    • G10K15/04—Sound-producing devices
    • G10K15/043—Sound-producing devices producing shock waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/008—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms using shock waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/04—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with hydraulic or pneumatic drive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/225—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • A61B17/2251—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00544—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated pneumatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/92—Impactors or extractors, e.g. for removing intramedullary devices
    • A61B2017/922—Devices for impaction, impact element
    • A61B2017/924—Impact element driving means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/92—Impactors or extractors, e.g. for removing intramedullary devices
    • A61B2017/922—Devices for impaction, impact element
    • A61B2017/927—Returning means

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Description

本発明は、請求項１の前提部分に記載の生体組織治療用医療器具に関する。
このような医療器具は、骨折、骨付着部炎（enthesopathy）、腱疾患（tendopathy）並びに歯周症の患者における治癒過程を圧力波または衝撃波によって促進するために役立つ。別の応用例は、姿勢系および運動系の骨近辺の軟組織域における痛みの治療である。
従来知られている体外圧力波発生装置においては、圧力波または衝撃波は、音響反射器の焦点で、例えば、火花放電によって生じ、波動は波動によって治療する対象上に反射器を介して収束される。圧力波によって生体組織に微小損傷が生じ、その損傷によって生体が再生処置を講じると考えられている。
既知の圧力パルス源は収束された衝撃波を使用し、狭い焦点区域においてのみ効果を生じることができる。しかし、十分な治療結果を得るには波動によって骨折区域全体を均一に治療することが要求される。そのため、圧力パルス源の複雑な運動機構が必要とされ、かつ治療部位を繰返し探査するためにきわめて多くの時間が費やされる。
痛みの治療においては、既知の圧力パルス源を使用することによって別の問題に遭遇する。治療する区域を局在化するために治療中に使用する局在化装置（超音波装置およびＸ線装置）が痛みの源を正確に指示することができず、したがって医師は多くの個別パルスを、想定した痛みの源に投入することになる。
したがって、本発明の目的は、圧力波エネルギーを広範囲に簡単かつ安価な方法で均一に配分することができる圧力波発生装置を構成することにある。
本発明は、機械的に生じた圧力波を生体組織内に投入する平坦な（切り立っていない）出口面を備えた先の鈍いプローブ先端を備える伝達要素を有利な形で提供する。圧力波または衝撃波は、伝達要素の適用箇所への直接接触なしに伝達要素から適用箇所に伝播する。本発明は圧力波を収束しないことを目的とし、それによって波動の広い区域への投入を可能にする。この医療器具は、プローブ先端をテニス肘、踵の骨棘（heal spur）または歯周症等の適用箇所至近の体表面に配置することができる治療に特に適している。
圧力波発生装置は、駆動要素によりハウジング内を案内される往復運動するビータ部（beater part）を備えることが好ましく、該ビータ部は、１回または数回の衝撃を伝達要素に及ぼし、それによって伝達要素内に衝撃による圧力波を誘発し、圧力波は伝達要素の先の鈍いプローブ先端の出口境界面に伝播する。したがって、圧力波は簡単な方法で機械的に発生する。プローブ先端の急速な運動により、高い圧力ピーク値を有する圧力波を発生することができる。圧力波は生体組織内に伝播し、収束されない。このような装置によって生じる圧力波は、収束された圧力波を発生する圧力波発生装置によって発生される圧力波の短い立上り時間には及ばないが、その最大圧力ピークは決して弱くない。収束されない圧力波は、生体組織内の適用箇所に放射状に伝播する。
本発明の、本質的な利点はこの医療器具が簡潔かつ安価な設計であり、そのコストが従来知られている圧力波発生装置よりはるかに低いことである。
この医療器具は容易に使用でき、治療する体の部分に障害を与えずに配置することができる小型の可搬式装置として設計することができる。この装置は、消耗品を必要とせず、特に、治療する区域がプローブ先端の近辺にあるので位置決め手段を必要としない。
ビータ部は、伝達要素と同軸に配置することが好ましい。それによって、ビータ部が伝達要素の入口境界面を打撃時に、ビータ部と伝達要素間の直接的なパルス交換が得られる。
特に、整形外科の応用例において、複数の個別圧力波を生体組織内に投入して最適の効果を達成することが有利である。そのため、駆動要素はビータ部の周期的往復運動が可能になるように設計することが好ましい。打撃振動数は約１から３０ヘルツ、好ましくは約６から２０ヘルツに及ぶ。
好ましい実施形態においては、伝達要素はハウジング内で軸方向にかつ直線的に案内され、弾性／減衰要素が伝達要素とハウジングの間に配置される。このようにして、伝達要素のハウジングからの軸方向の減結合（decoupling）が達成される。さらに、この弾性／減衰要素は伝達要素を各圧力波投入後にホーム・ポジションに復帰させ、また伝達要素の可動範囲を規制する。圧力波の生体組織への投入は、伝達要素の出口境界面の大きなストロークを要するものでなく、伝達要素の変位の結果でなくむしろその伸張の結果として行われるべきである。したがって、圧力波の生体組織内への投入はプローブ先端の大きな移動なしに起こる。
伝達要素の入口境界面に作用する衝撃は、伝達要素とハウジングの間に配置された減衰要素の圧縮により、プローブ先端を１ミリメートル未満、好ましくは０．５ミリメートル未満だけ変位させる。
ビータ部と伝達要素の間に、衝撃をビータ部から伝達要素に伝達する中間要素を配置することができる。この中間要素は、適用区域方向への駆動要素のスクリーニング（screening）の向上、あるいは圧力波の向きの変更、あるいは圧力波特性に影響を及ぼす働きをすることができる。
ビータ部ガイドの基端側の端部にビータ部の磁気ホルダを配置することができ、それによってビータ部は駆動手段によって再び加速されるまで基端側の端部位置に保持される。
先の鈍いプローブ先端は縁を丸めた平坦な（切り立っていない）出口境界面を備えることが好ましい。伝達要素の出口境界面は可能な限り大きくし、それによって圧力波伝達中の高い効率が達成される。縁を丸めることにより、皮膚表面の損傷を防止する。
プローブ先端は、縁を丸めた凹状の出口境界面を有することもできる。
伝達要素の別の実施形態においては、出口境界面の径を入口境界面よりかなり大きくすることができる。このような出口境界面によって圧力波を投入する大きな伝達表面が保証され、それによって、投入された比圧力波エネルギー（specific pressure wave energy）が減少して皮膚表面が保護される。
プローブ先端と生体組織上の投入位置の間に、インピーダンス整合媒質を配置し、それによって圧力波の生体組織内への投入を向上させることができる。適切な糊状インピーダンス整合媒質としては、例えば、超音波ゲルやワセリン等の他の糊状物質がある。
インピーダンス整合のためには、伝達要素は伝達挙動を向上させる様々な材料により製作することができる。適切な材料を選択することによって、圧力波の伝達挙動および伝達要素それぞれに影響を及ぼし、それによって生体組織内への投入に影響を及ぼすことができる。様々な材料から単一部品（single-piece）の伝達要素を製造するのは、圧力波の生体組織への低損失投入によってインピーダンス整合を可能にするためである。
伝達要素の長さは、約２０から１００ミリメートルの間に及ぶ。様々な交換可能な伝達要素によって所望の治療方法に合わせた調整が可能になる。
以下に、本発明の実施形態を図面を参照して説明する。
図１は、医療器具の断面図である。
図２および図３は、伝達要素の代替実施形態を示す図である。
図１に示すハンドピース１は、空気圧シリンダ６を収容するハウジング４を備え、空気圧駆動手段１４の助けにより、シリンダ６を同軸リング状に囲む動圧チャンバ８と関連して、シリンダ内でビータ部１０が２つの末端位置間を往復する。あるいはビータ部１０は、液圧手段、機械的手段、電磁気的手段、その他の駆動手段により加速することもできる。ビータ部１０の電磁的加速の場合には、空気圧式アクチュエータを使用した場合に約１００から２００ミリメートルである加速経路を短縮することが可能である。
ビータ部１０の基端側の端部位置には、磁気ホルダ２８がシリンダ６の基端側の端部２０に配置され、連結部３２を介して加えられる空気圧によりビータ部１０が再びシリンダ６の末端側の端部１８の方向に加速されるまで金属ビータ部１０をその基端側の端部位置に保持する。ビータ部１０の運動方向に見てビータ部上流の空気は、シリンダ６の末端側の端部１８に位置する環状の溝穴１６を介して動圧チャンバ８に供給される。ビータ部１０の加速によってビータ部は、シリンダ６から末端側に配置された伝達要素２の入口境界面２６を高い末端速度、例えば、５から２０メートル毎秒で打撃する。伝達要素２は、先の鈍いプローブ先端２２および平面または凸面の出口境界面２４を有する金属プローブを備える。ビータ部１０は、１回または数回の衝撃を伝達要素２に与え、伝達要素２はビータ部１０により誘起された圧力波を出口境界面２４に伝達し、出口境界面を生体組織内に投入する。
伝達要素２はハウジング４内で直線的に案内されており、かつビータ部１０と同軸に案内することが好ましい。ハウジング４は、伝達要素２を交換するために取外し可能な上部５を備える。伝達要素２は上部５の穴内に支持され、上部５の前部でＯリング２５によってシールされる。伝達要素２の環状カラー３は、伝達要素２の環状カラー３とハウジング４の上部５の間に配置された弾性／減衰要素３０との当接要素として働き、これにより伝達要素２はハウジング４から軸方向に減結合（decouple）される。さらに、弾性／減衰要素３０は伝達要素２のリセット機能を有し、圧力波が加わる都度その後に伝達要素をその基端側のホーム・ポジションに押し戻す。同時に、弾性／減衰要素は圧力波が加わる間の伝達要素の可動範囲を規制する。圧力波の生体組織内への投入のためには、伝達要素の変位は必要なく、むしろ外傷防止のために望ましくない。圧力波はもっぱら圧力波の伝播により生じる伝達要素２の伸張によって生体組織内に投入するべきである。
動圧チャンバ８内で増大する動圧は、空気圧接続部３２で優勢な圧力が省かれた時に、ビータ部１０を伝達要素２がある末端側の端部位置から磁気ホルダ２８がある基端側の端部位置に戻すのに十分である。接続部３２における空気圧は０．５ＭＰａ（５バール）に及ぶことがある。伝達要素２をある一定の長さに調節する目的で、または圧力波のある一定の特性を生成する目的で、長さおよび質量の異なるビータ部１０と最大打撃速度の異なるビータ部１０を選択することができる。
伝達要素２の基端側の入口境界面２６の径はビータ部１０の径と実質的に同じであるが、出口境界面２４の径は、例えば、入口境界面２６の径より２倍大きくすることもできる。ビータ部１０の長さは、その径を超えることが好ましい。それによって、シリンダ６内における案内がより良くなる。さらに、ビータ部１０の長さを変えることにより、シリンダ６および伝達要素２の入口境界面２６の径を変える必要なく容易にその質量を変えることができる。
伝達要素２の基端側の端部は溝付きスリーブ１２内を案内され、Ｏリング３５によりこのスリーブ内で径方向にシールされる。スリーブ１２は、伝達要素２の基端側の円錐形の端部と共に、動圧チャンバ８と、ビータ部１０から末端側に位置するシリンダ６の中空スペースとの間の接続部を形成する。
圧力波は、約１から３０ヘルツ、好ましくは６から２０ヘルツの打撃振動数で生じる。プローブ先端２２は、最大約１ミリメートル、好ましくは０．５ミリメートル未満移動する。
図２は、縁を丸めた平坦で先の鈍いプローブ先端２２を有する伝達要素２を示す。
図３による伝達要素２の実施形態においては、出口境界面２４が入口境界面２６に比べてかなり拡大されている。出口境界面２４と入口境界面２６の直径比率は約２から３に及ぶ。
この医療器具は、機械的に生じた圧力波を平坦な入口境界面を有する先の鈍いプローブを介して生体組織内に非収束投入することにより実施される生体硬軟組織の治療、特に骨折、骨付着部炎、腱疾患および歯周症等の骨障害の治療、並びに姿勢系および運動系の骨近辺の軟組織域における痛みの治療を可能にする。
伝達要素２は、圧力波の生体組織内への低損失投入を保証するために様々な材料で製作され、これによりインピーダンス整合を達成することができる。また、様々な材料を軸方向に見て縦列に配置することも考えられる。The present invention relates to a medical device for treatment of biological tissue according to the premise part of claim 1.
Such medical devices are useful for accelerating the healing process in pressure waves or shock waves in patients with fractures, enthesopathy, tendonopathy and periodontitis. Another application is the treatment of pain in soft tissue areas near the bones of posture and motor systems.
In previously known extracorporeal pressure wave generators, a pressure wave or shock wave is generated at the focal point of an acoustic reflector, for example, by a spark discharge, and the wave is focused via a reflector onto an object to be treated by the wave. . It is believed that microscopic damage occurs in living tissue due to pressure waves, and the living body takes a regenerative treatment due to the damage.
Known pressure pulse sources use focused shock waves and can only be effective in narrow focal areas. However, in order to obtain a sufficient treatment result, it is required to treat the entire fractured area uniformly by waves. Therefore, a complicated motion mechanism of the pressure pulse source is required, and a great deal of time is spent to repeatedly explore the treatment site.
In the treatment of pain, another problem is encountered by using known pressure pulse sources. The localization devices (ultrasound devices and x-ray devices) used during treatment to localize the area to be treated cannot accurately indicate the source of pain, so the physician can send many individual pulses. , Will be put into the assumed source of pain.
Accordingly, an object of the present invention is to construct a pressure wave generator that can uniformly distribute pressure wave energy over a wide range by a simple and inexpensive method.
The present invention advantageously provides a transmission element comprising a blunt probe tip with a flat (non-sharp) exit surface for injecting mechanically generated pressure waves into living tissue. The pressure wave or shock wave propagates from the transmission element to the application site without direct contact to the application site of the transmission element. The present invention aims at not converging pressure waves, thereby enabling the injection of waves into a wide area. This medical device is particularly suitable for treatments in which the probe tip can be placed on the body surface close to the application site, such as tennis elbow, heal spur or periodontal disease.
The pressure wave generating device preferably comprises a reciprocating beater part guided in a housing by a drive element, the beater part exerting one or several impacts on the transmission element, thereby A pressure wave due to impact is induced in the transmission element, and the pressure wave propagates to the outlet interface of the blunt probe tip of the transmission element. Therefore, the pressure wave is generated mechanically in a simple manner. Due to the rapid movement of the probe tip, a pressure wave having a high pressure peak value can be generated. The pressure wave propagates into the living tissue and is not converged. The pressure wave produced by such a device does not extend to the short rise time of the pressure wave generated by the pressure wave generator that generates the focused pressure wave, but its maximum pressure peak is never weak. The unfocused pressure wave propagates radially to the application site in the living tissue.
An essential advantage of the present invention is that the medical device has a simple and inexpensive design and its cost is much lower than previously known pressure wave generators.
This medical device can be easily used and designed as a small portable device that can be placed without damaging the body part to be treated. This device does not require consumables and in particular does not require positioning means because the area to be treated is in the vicinity of the probe tip.
The beater part is preferably arranged coaxially with the transmission element. Thereby, a direct pulse exchange between the beater part and the transmission element is obtained when the beater part strikes the inlet interface of the transmission element.
In particular, in orthopedic applications, it is advantageous to achieve the optimum effect by injecting a plurality of individual pressure waves into the living tissue. Therefore, it is preferable that the drive element is designed so that the beater portion can be periodically reciprocated. The striking frequency ranges from about 1 to 30 hertz, preferably from about 6 to 20 hertz.
In a preferred embodiment, the transmission element is guided axially and linearly in the housing and an elastic / damping element is arranged between the transmission element and the housing. In this way, axial decoupling from the housing of the transmission element is achieved. Further, this elastic / damping element returns the transmission element to the home position after applying each pressure wave, and restricts the movable range of the transmission element. The injection of the pressure wave into the living tissue does not require a large stroke at the exit interface of the transmission element and should be done as a result of its extension rather than as a result of displacement of the transmission element. Therefore, the injection of the pressure wave into the living tissue occurs without a large movement of the probe tip.
The impact acting on the inlet interface of the transmission element causes the probe tip to be displaced by less than 1 millimeter, preferably less than 0.5 millimeter, due to compression of the damping element located between the transmission element and the housing.
An intermediate element that transmits an impact from the beater portion to the transmission element can be disposed between the beater portion and the transmission element. This intermediate element can serve to improve the screening of the drive element in the direction of the application area, or to change the direction of the pressure wave, or to influence the pressure wave characteristics.
A magnetic holder for the beater unit can be arranged at the proximal end of the beater unit guide, whereby the beater unit is held in the proximal end position until it is accelerated again by the drive means.
The blunt probe tip preferably comprises a flat (non-sharp) exit interface with rounded edges. The exit interface of the transmission element is as large as possible, thereby achieving high efficiency during pressure wave transmission. Prevents skin surface damage by rounding the edges.
The probe tip can also have a concave exit interface with rounded edges.
In another embodiment of the transmission element, the diameter of the exit interface can be much larger than the entrance interface. Such an exit interface ensures a large transmission surface for injecting pressure waves, thereby reducing the applied specific pressure wave energy and protecting the skin surface.
An impedance matching medium is disposed between the probe tip and the input position on the living tissue, thereby improving the input of the pressure wave into the living tissue. Suitable pasty impedance matching media include, for example, other pasty substances such as ultrasonic gels and petrolatum.
For impedance matching, the transmission element can be made of various materials that improve the transmission behavior. By selecting an appropriate material, it is possible to influence the pressure wave transmission behavior and each of the transmission elements, thereby affecting the injection into the living tissue. The single-piece transmission element is manufactured from various materials in order to allow impedance matching by low loss injection of pressure waves into the living tissue.
The length of the transmission element ranges between about 20 and 100 millimeters. A variety of interchangeable transmission elements allows adjustment to the desired treatment method.
Embodiments of the present invention will be described below with reference to the drawings.
FIG. 1 is a cross-sectional view of a medical device.
2 and 3 show alternative embodiments of the transmission element.
The handpiece 1 shown in FIG. 1 comprises a housing 4 that houses a pneumatic cylinder 6, with the aid of a pneumatic drive means 14, in connection with a dynamic pressure chamber 8 that surrounds the cylinder 6 in a coaxial ring shape, 10 reciprocates between the two end positions. Alternatively, the beater unit 10 can be accelerated by hydraulic means, mechanical means, electromagnetic means, or other driving means. In the case of electromagnetic acceleration of the beater unit 10, it is possible to shorten the acceleration path which is about 100 to 200 millimeters when a pneumatic actuator is used.
The magnetic holder 28 is disposed at the proximal end 20 of the cylinder 6 at the proximal end position of the beater unit 10, and the beater unit 10 is again attached to the cylinder 6 by the air pressure applied via the connecting portion 32. The metal beater 10 is held at the proximal end position until accelerated in the direction of the distal end 18. The air upstream of the beater unit as viewed in the direction of motion of the beater unit 10 is supplied to the dynamic pressure chamber 8 via an annular slot 16 located at the end 18 on the distal end side of the cylinder 6. Due to the acceleration of the beater part 10, the beater part strikes the inlet interface 26 of the transmission element 2 arranged distally from the cylinder 6 at a high end velocity, for example 5 to 20 meters per second. The transmission element 2 comprises a metal probe having a blunt probe tip 22 and a planar or convex exit interface 24. The beater unit 10 gives one or several impacts to the transmission element 2, and the transmission element 2 transmits the pressure wave induced by the beater unit 10 to the outlet boundary surface 24 and inputs the outlet boundary surface into the living tissue. To do.
The transmission element 2 is preferably guided linearly in the housing 4 and guided coaxially with the beater part 10. The housing 4 comprises an upper part 5 which can be removed for replacing the transmission element 2. The transmission element 2 is supported in a hole in the upper part 5 and is sealed by an O-ring 25 at the front part of the upper part 5. The annular collar 3 of the transmission element 2 serves as an abutment element for the elastic / damping element 30 arranged between the annular collar 3 of the transmission element 2 and the upper part 5 of the housing 4, so that the transmission element 2 is removed from the housing 4. Decoupled in the axial direction. Furthermore, the elastic / damping element 30 has a reset function of the transmission element 2 and pushes the transmission element back to its home position every time a pressure wave is applied. At the same time, the elastic / damping element restricts the movable range of the transmission element during the application of pressure waves. For the injection of the pressure wave into the living tissue, the displacement of the transmission element is not necessary, but rather is undesirable for preventing trauma. The pressure wave should be introduced into the living tissue solely by the extension of the transmission element 2 caused by the propagation of the pressure wave.
The dynamic pressure that increases in the dynamic pressure chamber 8 is such that when the pressure prevailing at the pneumatic connection portion 32 is omitted, the beater unit 10 is moved from the end position of the transmission element 2 to the proximal side where the magnetic holder 28 is located. Is sufficient to return to the end position. The air pressure at the connection 32 may reach 0.5 MPa (5 bar). In order to adjust the transmission element 2 to a certain length or to generate a certain characteristic of the pressure wave, a beater portion 10 having a different length and mass and a beater portion 10 having a different maximum hitting speed are selected. be able to.
The diameter of the inlet interface 26 on the proximal end side of the transmission element 2 is substantially the same as the diameter of the beater unit 10, but the diameter of the outlet interface 24 is, for example, twice larger than the diameter of the inlet interface 26. You can also. The length of the beater unit 10 preferably exceeds the diameter. Thereby, the guidance in the cylinder 6 is better. Furthermore, by changing the length of the beater unit 10, it is possible to easily change its mass without having to change the diameters of the cylinder 6 and the inlet interface 26 of the transmission element 2.
The proximal end of the transmission element 2 is guided in the grooved sleeve 12 and is sealed radially in this sleeve by an O-ring 35. The sleeve 12 together with the conical end on the proximal side of the transmission element 2 forms a connection between the dynamic pressure chamber 8 and the hollow space of the cylinder 6 located distally from the beater part 10.
The pressure wave occurs at a striking frequency of about 1 to 30 hertz, preferably 6 to 20 hertz. The probe tip 22 moves up to about 1 millimeter, preferably less than 0.5 millimeter.
FIG. 2 shows a transfer element 2 having a flat, blunt probe tip 22 with rounded edges.
In the embodiment of the transmission element 2 according to FIG. 3, the outlet interface 24 is considerably enlarged compared to the inlet interface 26. The diameter ratio between the outlet interface 24 and the inlet interface 26 ranges from about 2 to 3.
This medical device is used to treat hard and soft tissues, particularly fractures, bones, which are performed by non-convergent injection of mechanically generated pressure waves into a living tissue through a blunt probe having a flat entrance interface. Enables treatment of bone disorders such as adherenceitis, tendon disease and periodontitis, as well as pain in the soft tissue area near the bone in the posture and motor systems.
The transmission element 2 can be made of various materials to ensure low-loss injection of pressure waves into the living tissue, thereby achieving impedance matching. It is also conceivable to arrange various materials in a column when viewed in the axial direction.

Claims (11)

生体外の圧力波の発生装置を具え、
前記圧力発生装置は、発生した圧力波を生体内に投入するために伝達要素（２）を打撃するように構成され配列されたビータ部（１０）を含み、
前記伝達要素（２）は先の鈍いプローブ先端（２２）を有し、
前記プローブ先端（２２）は出口境界面（２４）を含み、
前記出口境界面（２４）は機械的に生じた非収束圧力波を生体組織内に投入する平坦または凸状の表面形状をなし、
前記ビータ部（１０）は前記伝達要素（２）を打撃するときに５から２０メートル毎秒に加速されて、前記プローブ先端（２２）を１ミリメートル未満変位させる
生体組織治療用医療器具であって、
前記圧力波の発生装置が、駆動手段（１４）の助けにより往復運動可能なビータ部（１０）を備え、該ビータ部はハウジング（４）内を案内され、かつ１回または数回の衝撃を伝達要素（２）に加え、ビータ部（１０）は伝達要素（２）に衝撃による圧力波を誘起し、圧力波は伝達要素（２）の先の鈍いプローブ先端（２２）の出口境界面（２４）まで伝播し、
軸方向に作用し圧力波が加わる間の伝達要素（２）の可動範囲を規制する弾性／減衰要素（３０）が伝達要素（２）とハウジング（４）の間に配置されることを特徴とする生体組織治療用医療器具。Including an in vitro pressure wave generator,
The pressure generator includes a beater unit (10) configured and arranged to strike the transfer element (2) to inject the generated pressure wave into the living body,
The transmission element (2) has a blunt probe tip (22);
The probe tip (22) includes an exit interface (24);
The outlet interface (24) has a flat or convex surface shape for injecting mechanically generated non-convergent pressure waves into living tissue,
The beater portion (10) is a medical device for treatment of biological tissue that is accelerated from 5 to 20 meters per second when striking the transmission element (2) to displace the probe tip (22) by less than 1 millimeter ,
The pressure wave generator comprises a beater part (10) which can reciprocate with the aid of drive means (14), the beater part being guided in the housing (4) and subjected to one or several impacts. In addition to the transmission element (2), the beater section (10) induces a pressure wave due to an impact in the transmission element (2), and the pressure wave is generated at the outlet interface (22) of the blunt probe tip (22) of the transmission element (2). 24)
An elastic / damping element (30) is provided between the transmission element (2) and the housing (4) to restrict the movable range of the transmission element (2) while acting in the axial direction and applying pressure waves. A medical device for treating biological tissue . ビータ部（１０）の打撃振動数が約１から３０ヘルツ、好ましくは６から２０ヘルツに及ぶことを特徴とする請求項１に記載の医療器具。Beater portion (10) striking frequency about 1 to 30 Hertz, medical instrument according to claim 1, preferably it is characterized by ranging from 6 to 20 hertz. ビータ部（１０）が伝達要素（２）を繰返し打撃するために周期的に往復運動可能であり、ビータ部（１０）および伝達要素は自動的にリセット可能であることを特徴とする請求項１に記載の医療器具。Beater portion (10) is periodically reciprocatingly for impacting repeatedly transmitting element (2), according to claim 1, wherein the beater portion (10) and the transmission element are automatically resettable Medical device as described in. 衝撃によりプローブ先端（２２）が０．５ミリメートル未満変位されることを特徴とする請求項１から３のいずれか１つに記載の医療器具。Medical device according to any one of claims 1 to 3, the probe tip (22) is characterized in that it is displaced less than 0.5 mm by the impact. ビータ部（１０）と伝達要素（２）の間に中間要素が配置され、該中間要素は衝撃をビータ部（１０）から伝達要素（２）に伝達することを特徴とする請求項１から４のいずれか１つに記載の医療器具。Is an intermediate element disposed between the beater portion (10) and transmission element (2), the intermediate element from claim 1, wherein the transmitting impact transmission element (2) from the beater portion (10) 4 A medical device according to any one of the above. ビータ部（１０）の磁気ホルダ（２８）が、ビータ部（１０）のガイド（６）の基端側の端部（２０）に配置されることを特徴とする請求項１から５のいずれか１つに記載の医療器具。The magnetic holder (28) of the beater unit (10) is arranged at the proximal end (20) of the guide (6) of the beater unit (10) . medical instrument according to one. 先の鈍いプローブ先端（２２）が縁を丸めた平坦な出口境界面（２４）を備えることを特徴とする請求項１から６のいずれか１つに記載の医療器具。7. A medical device according to any one of the preceding claims, characterized in that the blunt probe tip (22) comprises a flat outlet interface (24) with rounded edges. プローブ先端（２２）が凸状の出口境界面（２４）を備えることを特徴とする請求項１から６のいずれか１つに記載の医療器具。The medical device according to any one of claims 1 to 6, characterized in that the probe tip (22) comprises a convex outlet interface (24). 伝達要素（２）が入口境界面（２６）より径の大きい出口境界面（２４）を備えることを特徴とする請求項１から８のいずれか１つに記載の医療器具。9. A medical device according to any one of the preceding claims, characterized in that the transmission element (2) comprises an outlet interface (24) having a larger diameter than the inlet interface (26). 糊状のインピーダンス整合媒質がプローブ先端（２２）と生体組織の投入位置の間に置かれ、それによって圧力波の生体組織内への投入が改善されることを特徴とする請求項１から９のいずれか１つに記載の医療器具。 Pasty impedance matching medium is placed between the loading position of the biological tissue probe tip (22), whereby the claim 1, characterized in that the introduction of the pressure wave in a living body tissue is improved 9 The medical device as described in any one . 伝達要素（２）の長さが約２０から１００ミリメートルに及ぶことを特徴とする請求項１から１０のいずれか１つに記載の医療器具。11. A medical device according to any one of the preceding claims, characterized in that the length of the transmission element (2) ranges from about 20 to 100 millimeters.
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CA2287715A1 (en) 2001-04-26
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US6413230B1 (en) 2002-07-02

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